Multiple Intervention and AUdit in Renal Diseases to Optimize Care: the MAURO Study.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 788
- Locations
- 1
- Primary Endpoint
- A composite renal and cardiovascular (CV) end point, i.e. >30% decrease in the GFR, dialysis, transplantation, death or CV event.
Study Overview
Brief Summary
Test whether the intensive intervention improves renal and cardiovascular outcomes in patients with chronic renal insufficiency.
Test whether a multi-method intensive intervention including clinical Audit improves adherence to a series of quality indicators relevant to hypertension control, proteinuria, treatment of dyslipidemia, anemia, calcium and phosphate alterations in patients with chronic renal insufficiency.
Detailed Description
Background:
Guidelines are currently promoted as a means for linking evidence based medicine to clinical practice and for reducing variation in clinical practice (1). However, there is ample evidence that implementation of evidence-based recommendations for prevention and management of renal disease progression and associated cardiovascular complications remain largely unsatisfactory (2). Deficiencies exist in the treatment of dyslipidemia and hypertension, inadequate use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers as well as in the treatment of anemia and of alterations in calcium and phosphate metabolism (2). Furthermore patients with diabetes mellitus infrequently receive recommended treatment for elevated glycosylated haemoglobin levels, hypertension, and dyslipidemia.
The importance of interventions to increase adherence to practice guidelines and to improve disease control is now widely perceived. However, little is known about the relative effectiveness of different implementation strategies. Fresh research is required to develop and validate practical strategies for improving the provision of evidence-based medicine in nephrology clinics. In particular, studies addressing multiple common, chronic conditions which simultaneously affect the population of patients with chronic renal insufficiency are now felt as of primary importance. The study was approved by Ethical Committees of all Nephrology Units participating into the MAURO study.
Specific hypotheses:
This study is designed as a clinical trial aimed at assessing whether a quality improvement intervention is more effective than standard care for improving adherence to a series of quality indicators relevant to the prevention of renal disease progression and associated cardiovascular complications. The multi-method quality improvement intervention (intensive intervention) adds telephone and e-mail contacts (for quality improvement facilitation) and audits to the approach of periodic guideline dissemination used in standard care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Creatinine >1.5 -4.0 mg/dL (males) and >1.3-3.5 mg/dL (females).
- •Age range :18 - 75 years
Exclusion Criteria
- •Transplanted
- •Affected by cancer or diseases in the terminal phase
- •Non acute or rapidly evolving renal diseases.
Outcomes
Primary Outcomes
A composite renal and cardiovascular (CV) end point, i.e. >30% decrease in the GFR, dialysis, transplantation, death or CV event.
Time Frame: 3 years
Secondary Outcomes
- The primary renal unit-level outcome is the percentage of performance targets achieved. The primary patient-level outcome is the percentage of patients for whom the recommended process measures occurs.(3 years)
Investigators
Carmine Zoccali
Prof.
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy